Cryomedical Sciences
This article was originally published in The Gray Sheet
Executive Summary
FDA will consider clearing the CMS urethral warming device for market via 510(k) if four conditions are met, the firm reports following a Feb. 2 meeting with FDA. The company must: submit "a new 510(k) designating the warmer as an 'accessory' to the already cleared AccuProbe or other cryosurgical devices for use in general urological procedures"; submit clinical data; inform existing CMS warmer investigational sites that the agency considers the study a "significant risk device study" requiring FDA clearance of the investigational protocol and plan; and submit an investigational device exemption application to FDA for continuing and further studies of the warmer. FDA recently had told the firm that the CMS urethral warmer would require a premarket approval application ("The Gray Sheet" Jan. 24, In Brief)
You may also be interested in...
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.